One-Step AFP Strip Rapid Test

One-Step AFP Strip Rapid Test

INTENDED USE

The AFP Gold Rapid Screen Test (RST) is a chromatographic immunoassay for the detection of alpha fetoprotein(AFP) in human serum or plasma.

Assay Time: 10-20 minutes

Sample: serum / plasma

PRINCIPLE

The AFP RST is a chromatographic immunoassay (CIA) for the detection of AFP in human serum or plasma. Specific antibody against AFP re-coated onto membrane as a capture reagent on the test region. During the test, specimen is allowed to react with the colloidal gold particles, which have been labeled with other specific antibodies. If AFP present, a pink colored band will develop on the membrane in proportion to the amount of AFP presented in the specimen. Absence of this pink colored band in the test region suggests a negative result. To serve as a procedural control, a pink colored band in the control region will always appear regardless the presence of AFP.

REAGENTS AND MATERIALS PROVIDED

1.  One pouched cassette with desiccant.

2.        One piece of operating instruction.

WARNING AND PRECAUTIONS

1.  For in vitro diagnostic use only.

2.  Do not use after expiration date.

3.  Test device should remain sealed until use.

4.  The device stored at 4℃ should be balanced to room temperature prior to use.

5.  Desiccant in the sealed pouch, don’t eat it.

STORAGE

The kits should be stored at temperature 4-30°C, the sealed pouch for the duration of the shelf life (24months).

SAMPLE COLLECTION AND PREPARATION

Plasma

1.        Have a certified phlebotomies collect whole blood into a purple, blue or green top collection tube (containing EDTA, citrate or heparin, respectively) by veinpuncture.

2.        Separate the plasma by centrifugation.

3.        Carefully withdraw the plasma for testing or label and store it at 2-8°C for up to two weeks. Plasma may be frozen at -20°C for up to one year.

Serum

1.        Have a certified phlebotomies collect whole blood into a red top collection tube (containing no anticoagulants) by veinpuncture.

2.        Allow the blood to clot.

3.        Separate the serum by centrifugation.

4.         Carefully withdraw the serum for testing or label and store it at 2-8°C for up to two weeks. Serum may be frozen at -20°C for up to one year.

ASSAY PROCEDURE

1.  Remove the device from pouch by tearing.

2.  Add 2-3 drops (70-100ml) of specimen to the sample well.

3.  Read the result in 10-20 minutes